Willow Laboratories · 2 hours ago
Quality Manager
Irvine, CA
Full-time
Onsite
Mid, Senior Level
5+ years expWillow Laboratories is focused on the development of medical technology and innovative products that save lives. The Quality Manager will lead the corporate product quality systems, including setting quality goals and managing all aspects of product quality and documentation for advanced electronic medical devices.
FitnessHealth CareHospitalInformation TechnologyMedical DeviceSoftware
Responsibilities
Defines, develops, and implements quality system procedures, work instructions, and forms
Must work with limited supervision and will be involved in and have input to project planning
Proficient in clearly communicating directions and in influencing people in adopting the best solutions, tools, working practices and promotes cooperation in defining an excellent technical product
Initiates and performs internal and supplier audits
Works in collaboration with R&D Engineers and executes the quality tasks of the NPD (New product Development) process, such as Verification and Validation of new products, Risk Management, and Quality Control
Works with Engineering and Manufacturing regarding product and process improvements
Initiates and participates in Continuous Improvement projects
Coordinates the quality aspect of Customer Complaints and CAPA processes
Qualification
Required
BS in Mechanical or Electrical Engineering with minimum of 5 years of working experience, as a Quality Engineer, in a medical device manufacturing environment is a must
Excellent conceptual, analytical, and problem-solving ability
Good communication skills, both verbal and written, and the ability to interface effectively with engineering and manufacturing personnel
Working experience with ISO 13486 is a must
Working experience with investigation tools such as Fishbone diagram, Brainstorming, and Pareto charts is a must
Quality Engineer and Quality Auditor certifications (CQE, CQA) are a plus
Working experience with Minitab or any other data analysis software is a big plus
Use of ERP systems to support the quality system and quality initiatives
Proven competencies in: Analysis and reporting, Communication and presentation, Customer focus, Change champion, MS Office suite (Office, Word, Excel, PowerPoint)
Preferred
Experience working in both large structured and small entrepreneurial organizations
Company
Willow Laboratories
Willow Laboratories, a health and wellness innovator based in Irvine, California who holds 127 issued patents, 48 pending patents, and technologies that are used by leading hospitals around the world.
51-200 employees
H1B Sponsorship
Willow Laboratories has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (5)
2022 (3)
2021 (3)
2020 (5)
Funding
Current Stage
Growth StageTotal Funding
$7.89M2017-11-29Series Unknown· $4.89M
2016-12-05Series Unknown· $3M
Recent News
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